Events

Recall of ORTHO VISION ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    129627
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics (ortho) is issuing this recall due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui) the system will not detect the change. if users deviate from normal process for changing patient samples the analyzer may not detect the change. in this case samples can be associated with another sample id which can potentially lead to erroneous test results being reported. this issue was identified internally by ortho. to date ortho has received no customer complaints or reports of patient injury due to this issue.

Device

ORTHO VISION ANALYZER
  • Model / Serial
    Model Catalog: 6904577 (Lot serial: > 10 serial numbers affected)
  • Product Description
    ORTHO VISION Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS